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Original research
Data-sharing recommendations in biomedical journals and randomised controlled trials: an audit of journals following the ICMJE recommendations
  1. Maximilian Siebert1,2,
  2. Jeanne Fabiola Gaba1,2,
  3. Laura Caquelin1,
  4. Henri Gouraud1,
  5. Alain Dupuy2,
  6. David Moher3,
  7. Florian Naudet1
  1. 1Univ Rennes, CHU Rennes, Inserm, CIC 1414 (Centre d’Investigation Clinique de Rennes), F-35000, Rennes, France
  2. 2Univ Rennes, CHU Rennes, REPERES (Recherche en Pharmaco-épidémiologie et Recours aux Soins), EA 7449, 35000, Rennes, France
  3. 3Center for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
  1. Correspondence to Maximilian Siebert; maximilian.siebert{at}univ-rennes1.fr

Abstract

Objective To explore the implementation of the International Committee of Medical Journal Editors (ICMJE) data-sharing policy which came into force on 1 July 2018 by ICMJE-member journals and by ICMJE-affiliated journals declaring they follow the ICMJE recommendations.

Design A cross-sectional survey of data-sharing policies in 2018 on journal websites and in data-sharing statements in randomised controlled trials (RCTs).

Setting ICMJE website; PubMed/Medline.

Eligibility criteria ICMJE-member journals and 489 ICMJE-affiliated journals that published an RCT in 2018, had an accessible online website and were not considered as predatory journals according to Beall’s list. One hundred RCTs for member journals and 100 RCTs for affiliated journals with a data-sharing policy, submitted after 1 July 2018.

Main outcome measures The primary outcome for the policies was the existence of a data-sharing policy (explicit data-sharing policy, no data-sharing policy, policy merely referring to ICMJE recommendations) as reported on the journal website, especially in the instructions for authors. For RCTs, our primary outcome was the intention to share individual participant data set out in the data-sharing statement.

Results Eight (out of 14; 57%) member journals had an explicit data-sharing policy on their website (three were more stringent than the ICMJE requirements, one was less demanding and four were compliant), five (35%) additional journals stated that they followed the ICMJE requirements, and one (8%) had no policy online. In RCTs published in these journals, there were data-sharing statements in 98 out of 100, with expressed intention to share individual patient data reaching 77 out of 100 (77%; 95% CI 67% to 85%). One hundred and forty-five (out of 489) ICMJE-affiliated journals (30%; 26% to 34%) had an explicit data-sharing policy on their website (11 were more stringent than the ICMJE requirements, 85 were less demanding and 49 were compliant) and 276 (56%; 52% to 61%) merely referred to the ICMJE requirements. In RCTs published in affiliated journals with an explicit data-sharing policy, data-sharing statements were rare (25%), and expressed intentions to share data were found in 22% (15% to 32%).

Conclusion The implementation of ICMJE data-sharing requirements in online journal policies was suboptimal for ICMJE-member journals and poor for ICMJE-affiliated journals. The implementation of the policy was good in member journals and of concern for affiliated journals. We suggest the conduct of continuous audits of medical journal data-sharing policies in the future.

Registration The protocol was registered before the start of the research on the Open Science Framework (https://osf.io/n6whd/).

  • clinical trials
  • statistics & research methods
  • epidemiology
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Footnotes

  • Twitter @ReiTheR_RCT, @dmoher

  • Correction notice Size of the figure 1 has been increased.

  • Contributors MS, JFG, AD, DM and FN conceived and designed the experiments. MS, JFG, LC and HG performed the experiments. MS and FN analysed the data. MS and FN interpreted the results. MS wrote the first draft of the manuscript. DM and FN contributed to the writing of the manuscript. MS, JFG, LC, HG, AD, DM and FN agreed with the results and conclusions of the manuscript. All authors have read them and confirm that they meet the ICMJE criteria for authorship. All authors had full access to all of the data (including statistical reports and tables) in the study and can take responsibility for the integrity of the data and the accuracy of the data analysis. MS is the guarantor.

  • Funding FN received funding from the French National Research Agency for the ReiTheR (Reproducibility in Therapeutic Research) project, which this article was part of (project number: ANR-17-CE36-0010).

  • Competing interests FN, MS and JFG received funding from the French National Research Agency for the submitted work.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available in a public, open access repository. All data and all materials are available on the OSF website: https://osf.io/n6whd/.